- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT03071627
Interpretation of Health News Items Reporting Results of Pre-clinical Studies With or Without Spin By French-speaking Population
Interpretation of Health News Items Reporting Results of Pre-clinical Studies With or Without Spin: A Randomized Controlled Trial Among French-speaking Population
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Health news is an important way to communicate updated medical research to the public. News items reporting the results of medical research attract a large audience. However, the quality of reporting in health news is questionable. The merits of a wide range of treatments and tests are overplayed and harms are underplayed. Several studies have shown the presence of spin (i.e., distorted presentation of study results) in health news. Distorted facts can be misleading and can affect the behaviour of physicians, healthcare providers and patients. However, little research has assessed whether spin can affect readers' interpretation of health news items.
Objective: To compare the interpretation of health news items reported with or without spin. News items reporting pre-clinical studies evaluating the effect of a pharmacological treatment that received high online public attention will be focused. "Spin" is defined as a misrepresentation of study results whatever the motive (intentionally or unintentionally) to highlight that the beneficial effect of the intervention in terms of efficacy and safety is greater than that shown by the results.
Hypothesis: The hypothesis of this study is that the spin can influence the reader's interpretation of health news items reporting results of pre-clinical studies.
Design: A randomized controlled trial
- Interventions: Health news items reporting results of pre-clinical studies with and without spin will be compared. A sample of health news items reporting the results of pre-clinical studies evaluating the effect of pharmacologic treatment and containing spin in the headline and text will be selected. Spin will be deleted in the selected news items and will be rewritten the news without spin.
- Participants: The participants will include French-speaking healthy population from Nutrinet santé.
- Sample size: For this RCT, the sample size will be 300 participants.
- Main outcome measures: The primary outcome will be participants' interpretation of the benefit of treatment after reading the news (What do you think is the probability that treatment X would be beneficial to patients? (scale, 0 [very unlikely] to 10 [very likely]).
- Expected results: This study will evaluate the impact of spin on the interpretation of news items reporting results of pre-clinical studies by French-speaking population.
- This study is approved by ethics review regulations by INSERM (CEEI-IRB): IRB00003888
Type d'étude
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Ile-de-france
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Paris, Ile-de-france, France, 75004
- Assistance Publique - Hôpitaux de Paris
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Native French speakers who can read the news
Exclusion Criteria:
-
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Autre
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Comparateur actif: Actualités avec Spin
Articles d'actualité rapportant les résultats d'études animales avec spin.
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Interpretation of news items with spin
|
Expérimental: Nouvelles sans spin
Articles d'actualité rapportant les résultats d'études animales sans détour.
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Interpretation of news items without spin
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Perception of beneficial effect of the treatment X. We ask participants, What do you think is the probability that treatment X would be beneficial to patients?
Délai: As the intervention is assigned (reading the news item) i.e., 1-2 hours
|
With the choices of answers on a 10 points Likert scale, (scale, 0 [very unlikely] to 10 [very likely])
|
As the intervention is assigned (reading the news item) i.e., 1-2 hours
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Perception of efficacy, safety, availability and clinical utility in existing clinical practice for the treatment X. We will ask the participants: What do you think is the size of the potential benefit for patients?
Délai: As the intervention is assigned (reading the news item) i.e., 1-2 hours
|
With the choice of answers on a 5 points scale, (scale, [none, small, moderate or large]) -- analysis none, small vs moderate, large
|
As the intervention is assigned (reading the news item) i.e., 1-2 hours
|
How safe do you think that treatment X would be for patients?
Délai: As the intervention is assigned (reading the news item) i.e., 1-2 hours
|
With the choices of answers on a 10 points Likert scale, (scale, 0 [very unsafe] to 10 [very safe])
|
As the intervention is assigned (reading the news item) i.e., 1-2 hours
|
Do you think this treatment should be offered to patients in the short term?
Délai: As the intervention is assigned (reading the news item) i.e., 1-2 hours
|
With the choices of answers on a 10 points Likert scale, (scale, 0 [absolutely no] to 10 [absolutely yes])
|
As the intervention is assigned (reading the news item) i.e., 1-2 hours
|
Do you think this treatment will make a difference in the existing clinical practice?
Délai: As the intervention is assigned (reading the news item) i.e., 1-2 hours
|
With the choices of answers on a 10 points Likert scale, (scale, 0 [absolutely no] to 10 [absolutely yes])
|
As the intervention is assigned (reading the news item) i.e., 1-2 hours
|
Collaborateurs et enquêteurs
Parrainer
Publications et liens utiles
Liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Anticipé)
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- ISB-002
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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